This introductory course focuses on the critical decisions made during a question-based label-driven approach to development of a pharmaceutical candidate from discovery through to product launch and marketing. The course highlights the decisions involved in the identification of a lead pharmaceutical candidate, conducting preclinical work to provide safety data to support the initial human clinical studies, establishing optimal therapeutic doses with an acceptable benefit-to-risk ratio, generating a label, and deciding to file an NDA or BLA. A key element of the module is a discussion of how the development of a pharmaceutical candidate is a stepwise approach of learning, confirming and affirming that together with the product label drives the pharmaceutical development process.
You should expect to spend approximately 6 hours of study time to complete the course.
Who Should Attend
Minimum Computer Requirements
This web-based module requires a current browser version, such as Google Chrome, Internet Explorer, or Safari; Adobe Acrobat Reader and Flash plug-ins; and a reliable network connection.
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$450.00 Registration Fee
Ask a Question
Contact one of our course instructors to ask a specific question about the program.
1 “The big picture about drug development will help me to design good clinical trials.”
2 “This information will allow me to bring these principles back to my day-to-day drug development plan.”